Story perspectives

FDA staff say Capricor's Phase 3 trial fails, shares tumble 65%

7/28/2026

Summary

Story summary

FDA staff reviewers said the Phase 3 HOPE-3 trial failed to meet its efficacy endpoint for Capricor Therapeutics’ deramiocel.
Reviewers noted Capricor used an unsigned draft statistical analysis plan version 1.1 instead of the finalized version 3.0.
Reviewers reported hypersensitivity in 42% of deramiocel patients versus 15% of placebo patients, suggesting unblinding.
Capricor shares fell more than 65% to $6.53 per share on July 27, 2026, ahead of an FDA advisory committee meeting on July 29, 2026.

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Story summary

FDA staff reviewers said the Phase 3 HOPE-3 trial failed to meet its efficacy endpoint for Capricor Therapeutics’ deramiocel.
Reviewers noted Capricor used an unsigned draft statistical analysis plan version 1.1 instead of the finalized version 3.0.
Reviewers reported hypersensitivity in 42% of deramiocel patients versus 15% of placebo patients, suggesting unblinding.
Capricor shares fell more than 65% to $6.53 per share on July 27, 2026, ahead of an FDA advisory committee meeting on July 29, 2026.